(288 days)
Neuromuscular electronic stimulator indicated for use under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions.
As powered muscle stimulator:
- Temporary Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy
- Increasing local blood flow in the treatment area
- Muscle re-education
- Prevention of post-surgical phlebo-thrombosis through immediate stimulation of calf muscles
- Maintaining or increasing range of motion
As external functional neuromuscular stimulator:
- Helps to relearn voluntary motor functions of the extremities
The device must be used by trained and qualified personnel.
The g.Estim FES is a constant-current powered muscle stimulator that can deliver rectangular electrical pulses with alternating polarities, lengths and amplitudes, or trains of such pulses. The device is battery supplied and can be connected via USB to a computer. It can be triggered via software or with a hand or foot switch.
The programmable parameters of the stimulator are: frequency, current, pulse width, ramp up and down and session length. The phase width and the stimulation current can be changed during stimulation; the other parameters can only be changed when the stimulator is stopped. Stimulation can be started and stopped using a configurable ramp for smooth on- and offsets. A LED shows the stimulus onset.
The system consists of the stimulator, a USB connector cable to connect the device to a host computer, patient cables for electrode connection and a software package including the driver and a graphical user interface. Optional trigger out cables and trigger in cables as well as a hand switch and foot switch to trigger the stimulator are available. The device stops stimulation if an over-load is detected or the electrodes are disconnected.
A foot switch or hand switch can be used to trigger the stimulator.
The device can perform an impedance measurement to check the electrodes impedance before the stimulation is done and can measure the actual stimulation current when a stimulation is done. The impedance measurement is done quickly so that the stimulation can rapidly be performed. If a high impedance is detected the stimulator does not stimulate.
g.Estim FES works in the same manner as the approved predicate devices.
The provided document is a 510(k) summary for the g.Estim FES device, a neuromuscular electronic stimulator. It details various technical characteristics of the device and compares them to predicate devices to demonstrate substantial equivalence, rather than providing an independent study report with acceptance criteria and performance against those.
Therefore, many of the specific questions about acceptance criteria for an AI/ML device study, such as sample size for test/training sets, expert ground truth establishment, MRMC studies, or standalone performance, are not directly applicable or answerable from this document, as it concerns a physical medical device (electrical stimulator) which relies on demonstrating technical similarity and compliance with safety standards rather than AI performance metrics.
However, I can extract the relevant information regarding acceptance criteria (in the context of demonstrating substantial equivalence to predicate devices) and the "study" or testing that proves the device meets these "acceptance criteria" as described in this 510(k) summary.
Device: g.Estim FES (Neuromuscular Electronic Stimulator)
Regulatory Submission: 510(k) Premarket Notification (K200088)
In the context of this 510(k) submission for a non-AI medical device, "acceptance criteria" refer to the technical specifications and safety standards a new device must meet or demonstrate substantial equivalence to, compared to legally marketed predicate devices. The "study" involves technical testing and comparison against these predicate devices.
Here's the information extracted and re-framed to address your request, acknowledging the nature of the device and its regulatory pathway:
1. A table of acceptance criteria and the reported device performance
The "acceptance criteria" for this conventional medical device are implicitly defined by the technical specifications of the predicate devices and relevant safety standards (IEC 60601 series). The "reported device performance" is the g.Estim FES's measured technical characteristics. The document presents a comparative table (starting on page 6 and continuing through page 14) that serves this purpose.
Below is a summarized version of key performance characteristics and their comparison, focusing on how the g.Estim FES meets the "acceptance criteria" by demonstrating equivalence or adherence to standards.
| Item/Characteristic | Acceptance Criteria (Predicate) | g.Estim FES Performance | Comment (Meets Acceptance Criteria?) |
|---|---|---|---|
| Intended Use | Powered Muscle Stimulation, Functional Neuromuscular Stimulation (as per predicates) | Same indications for use as primary predicate (Otto Bock STIWELL med 4) | Meets: Equivalent indications. |
| Power Sources | 110V AC, 60Hz +-10%; Battery Pack Li-ion 11.1V | USB and battery, 2 x 9 V | Meets: Powered by conventional batteries and USB, fulfills IEC 60601-1, equivalent in safety and effectiveness. |
| Patient Leakage Current | NC <100 µA, SFC < 500 µA (IEC levels) | NC max: < 1 µA, SFC max: 2.6 µA (Type BF according to IEC 60601-1) | Meets: Below IEC standard thresholds, equivalent in safety and effectiveness. |
| Number of Output Modes | 1, 3 (Tetanize, Surge, Pulse) | 1 | Meets: Similar parameter range as some predicates, equivalent in safety and effectiveness. |
| Number of Output Channels | 1, 4 | 1 | Meets: Provides one channel but equivalent in safety and effectiveness. |
| Regulated Output | Regulated current (constant current); Regulated voltage, constant current | Regulated voltage, constant current | Meets: Constant current regulated, equivalent in safety and effectiveness. |
| Software/Firmware/Microprocessor Control | Microprocessor control, Firmware, Software (present in predicates) | Microprocessor control, Firmware, Software | Meets: Uses software on host computer, stops stimulation on communication loss, equivalent in safety and effectiveness. |
| Automatic Overload Trip | Yes, No | Yes | Meets: Provides equal safety and effectiveness as it stops when required power cannot be delivered. |
| Automatic No-Load Trip | No, Yes | Yes | Meets: Provides equal safety and effectiveness as it stops when required power cannot be delivered. |
| Automatic Shut-off (Timer Range) | Yes, 10 min. | Yes | Meets: Same as predicate. |
| Max. Output Voltage (e.g., @ 500 Ω) | 92V, 50V | 30V | Meets: Lower voltage but equivalent in safety and effectiveness. |
| Max. Output Current (e.g., @ 500 Ω) | 184mA, 100mA | 0-60mA | Meets: Lower current but equivalent in safety and effectiveness. |
| Pulse Width | 182 µs, 50-400 µs | 50-400 µs | Meets: Equivalent range and therefore equivalent in safety and effectiveness. |
| Frequency | 1-80 Hz, 2-100 Hz, 1-140 Hz | 1-100 Hz | Meets: Equal range of frequency and therefore equivalent in safety and effectiveness. |
| Net Charge @ 500 Ω per pulse | Zero, max phase charge 56µC, 60µC, 40µC | Zero, max phase charge 24 µC | Meets: Same zero net charge and lower max. phase charge, equivalent in safety and effectiveness. |
| Max. Current Density | 0.132 mA/cm², 0.24 mA/cm², 12.5 mA/cm² | 3.056 mA/cm² | Meets: Slightly reduced current density but equivalent in safety and effectiveness. |
| Max. Power Density | 12 mW/cm², 16 mW/cm², 7.9 mW/cm² | 7.33 mW/cm² | Meets: Reduced power density but equivalent in safety and effectiveness. |
| Compliance with Standards | IEC60601-1, IEC60601-1-2, IEC60601-2-10 | IEC60601-1, IEC60601-1-2, IEC60601-2-10, ISO14971, IEC62304, IEC62366 | Meets: Applies more standards, demonstrating robust safety. |
2. Sample size used for the test set and the data provenance
For this type of device (a physical electrical stimulator), there isn't a "test set" in the sense of a dataset of patient images or readings. Instead, testing involves bench testing to verify the device's technical specifications and safety features.
- Sample Size for Test Set: Not specified in terms of patient data. The "test set" implies the physical device itself and its components undergoing engineering and safety verification. Typically, a specified number of manufactured units would be tested (e.g., N=1 or N=a small batch for verification of manufacturing consistency and performance). The document states, "The stimulator was tested with a data acquisition device and provides rectangular stimulation pulses with the necessary frequency and amplitude range." This implies at least one device was tested.
- Data Provenance: Not applicable for patient data. The provenance for the device is g.tec medical engineering GmbH, located in Austria. The testing itself is a part of the submission to the FDA for market clearance in the US, indicating the testing was sufficient for US regulatory purposes. The testing is in a pre-market setting (for 510(k) clearance), meaning it's a prospective test in the sense that it's designed to verify compliance before market entry.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable for this type of device. "Ground truth" for an electrical stimulator does not involve expert medical readers establishing clinical reality, but rather objective measurements against engineering specifications and relevant safety standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is not a study requiring reader adjudication of medical cases. The "adjudication" is implicitly through engineering verification and validation (V&V) processes against defined technical specifications and international standards (e.g., IEC 60601 series, ISO 14971, etc.).
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an electrical stimulator, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI assistance comparisons are irrelevant to its regulatory clearance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device. "Standalone performance" would refer to its technical operation according to specifications, which is what the "Accepted Criteria" table and the "Testing" section (807.92(b)(1)) describe. The device functions independently as an electrical stimulator, but its medical application requires trained and qualified personnel ("human-in-the-loop").
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is based on engineering specifications, direct objective measurements (e.g., voltage, current, pulse characteristics, impedance), and compliance with recognized international safety and performance standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, ISO 14971, IEC 62304, IEC 62366). The comparison to predicate devices also establishes a de-facto "ground truth" for acceptable performance characteristics based on previously cleared devices.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires training data.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device that requires training data and ground truth establishment in that context.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 29, 2020
g.tec medical engineering GmbH Christoph Guger CEO Siemingerstrasse 14 Schiedlberg, 4521 Austria
Re: K200088
Trade/Device Name: g.Estim FES Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF, GZI Dated: July 29, 2020 Received: July 31, 2020
Dear Dr. Guger:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
{1}------------------------------------------------
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Amber Ballard, PhD Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K200088
Device Name g.Estim FES
Indications for Use (Describe)
Neuromuscular electronic stimulator indical supervision for adjunctive therapy in the treatment of medical diseases and conditions.
As powered muscle stimulator:
- · Temporary Relaxation of muscle spasms
- · Prevention or retardation of disuse atrophy
- · Increasing local blood flow in the treatment area
- Muscle re-education
- Prevention of post-surgical phlebo-thrombosis through immediate stimulation of calf muscles
- · Maintaining or increasing range of motion
As external functional neuromuscular stimulator:
- · Helps to relearn voluntary motor functions of the extremities
The device must be used by trained and qualified personnel.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR 807.92(a).
807.92(a)(1)
Submitter Information
g.tec medical engineering GmbH Sierningstrasse 14 4521 Schiedlberg Austria
| Phone: | ++43 (7251) 22240-12 |
|---|---|
| Fax: | ++43 (7251) 22240-39 |
| Contact Person: | Christoph Guger |
| Date: | 28.10.2020 |
| 807.92(a)(2) | |
| Trade Name: | g.Estim FES |
| Common Name: | Electrical muscle stimulator |
| Classification Names(s): | Powered muscle stimulator(per 21 CFR section 21 CFR 890.5850)External functional neuromuscular stimulator(per 21 CFR section 21 CFR 882.5810) |
| Product Code: | IPF, GZI |
807.92(a)(3)
Predicate Devices/ Reference Devices
| Secondary Predicate | Reference | Primary Predicate | |
|---|---|---|---|
| Manufacturer: | Mettler ElectronicsCorp | Thought Technology Ltd | Otto Bock HealthcareProduct GmbH |
| Trade Name | SYS*STIM 208/208A | MyoTRac Infiniti | STIWELL med 4 |
| 510(k) document control number | K031017 | K053266 | K080950 |
g.tec medical engineering GmbH, Sierningstrasse 14, 4521 Schiedlberg, Austria, Europe, Tel .: +43 7251 22240, Fax: +43 7251 22240-39, office@gtec.at, www.gtec.at
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807.92(a)(4)
Device Description
The g.Estim FES is a constant-current powered muscle stimulator that can deliver rectangular electrical pulses with alternating polarities, lengths and amplitudes, or trains of such pulses. The device is battery supplied and can be connected via USB to a computer. It can be triggered via software or with a hand or foot switch.
The programmable parameters of the stimulator are: frequency, current, pulse width, ramp up and down and session length. The phase width and the stimulation current can be changed during stimulation; the other parameters can only be changed when the stimulator is stopped. Stimulation can be started and stopped using a configurable ramp for smooth on- and offsets. A LED shows the stimulus onset.
The system consists of the stimulator, a USB connector cable to connect the device to a host computer, patient cables for electrode connection and a software package including the driver and a graphical user interface. Optional trigger out cables and trigger in cables as well as a hand switch and foot switch to trigger the stimulator are available. The device stops stimulation if an over-load is detected or the electrodes are disconnected.
A foot switch or hand switch can be used to trigger the stimulator.
The device can perform an impedance measurement to check the electrodes impedance before the stimulation is done and can measure the actual stimulation current when a stimulation is done. The impedance measurement is done quickly so that the stimulation can rapidly be performed. If a high impedance is detected the stimulator does not stimulate.
g.Estim FES works in the same manner as the approved predicate devices.
{5}------------------------------------------------
807.92(1)(5)
Indications for Use
Neuromuscular electronic stimulator indicated for use under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions.
As powered muscle stimulator:
- Temporary Relaxation of muscle spasms .
- Prevention or retardation of disuse atrophy .
- Increasing local blood flow in the treatment area .
- · Muscle re-education
- . Prevention of post-surgical phlebo-thrombosis through immediate stimulation of calf muscles
- Maintaining or increasing range of motion .
As external functional neuromuscular stimulator
- · Helps to relearn voluntary motor functions of the extremities
The device must be used by trained and qualified personnel.
{6}------------------------------------------------
807.92(a)(6)
Technological Characteristics
| Item | g.tec medical engineeringGmbHg.Estim FESthis Submission | Mettler Electronics Corp.SYS*STIM 208/208AK031017 for IPF(secondary) | Thought Technology LtdMyoTrac Infiniti K053266for IPF (reference) | Otto Bock HealthcareProduct GmbHSTIWELL med4 K080950for IPF and GZI (primary) | Comments | |
|---|---|---|---|---|---|---|
| 1. | Intended use | Neuromuscular electronicstimulator indicated for useunder medical supervision foradjunctive therapy in thetreatment of medical diseasesand conditions. | Powered Muscle Stimulation | Muscle Stimulation and EMGBiofeedback | Neuromuscular electronicstimulator indicated for useunder medical supervision foradjunctive therapy in thetreatment of medical diseasesand conditions | Equivalent with predicateK080950, which covers allindications claimed also by thissubmission (including theindications of the otherpredicate devices).Indications for product code |
| 2. | Indication foruse | As powered musclestimulator:• Temporary Relaxationof muscle spasms• Prevention or retardationof disuse atrophy• Increasing local bloodflow in the treatmentarea• Muscle re-education• Prevention of post-surgical phlebo-thrombosis throughimmediate stimulationof calf muscles• Maintaining orincreasing range ofmotionAs external functionalneuromuscular stimulator:• Helps to relearnvoluntary motorfunctions of theextremitiesThe device must be used bytrained and qualified personnel. | • Temporary Relaxationof muscle spasms• Prevention or retardationof disuse atrophy• Increasing local bloodflow in the treatmentarea• Muscle re-education• Prevention of post-surgical phlebo-thrombosis throughimmediate stimulationof calf muscles• Maintaining orincreasing range ofmotion• Symptomatic relief ofchronic intractable pain,acute post traumaticpain or acute postsurgical pain | • Relaxation of musclespasms• Prevention or retardationof disuse atrophy• Increasing local bloodcirculation• Muscle re-education• Immediate post-surgicalstimulation of calfmuscles to preventvenous thrombosis• Maintaining orincreasing range ofmotion• Biofeedback, Relaxation& Muscle Re-Education | As powered musclestimulator:• Relaxation of musclespasm• Prevention or retardationof disuse atrophy• Increasing local bloodcirculation• Muscle re-education• Immediate post-surgicalstimulation of calfmuscles to preventvenous thrombosis• Maintaining orincreasing range ofmotionAs external functionalneuromuscular stimulator:• Helps to relearnvoluntary motorfunctions of theextremitiesAs a transcutaneouselectrical nerve stimulatorfor pain relief:• Symptomatic relief andmanagement of chronic(long-term), intractablepain | IPF (green) are equivalent insafety and effectiveness.Indications for product codeGZI (blue) are identical.Additional product codes of thepredicate devices not claimedby the current submission(orange) are:• reduction of pain (GZJ),• biofeedback (HCC)• incontinence treatments(KPI) |
| Item | g.tec medical engineeringGmbHg.Estim FES | Mettler Electronics Corp.SYS*STIM 208/208AK031017 for IPF | Thought Technology LtdMyoTrac Infiniti K053266for IPF | Otto Bock HealthcareProduct GmbHSTIWELL med4 K080950 | Comments | |
| this Submission | for IPF and GZI | |||||
| Adjunctive treatment inthe management of post-surgical pain and posttraumatic acute painAs a biofeedback device: Biofeedback, relaxationand muscle re-educationpurposesAs a nonimplanted electricalcontinence device: Acute and ongoingtreatment of stress, urgeor mixed urinaryincontinence and wherethe following resultsmay improve urinarycontrol: Inhibition of thedetruser musclesthrough reflexivemechanisms andstrengthening of pelvicfloor muscles Incontinence treatmentfor assessing EMGactivity of the pelvicfloor and accessorymuscles such as theabdominal and thegluteus muscles | ||||||
| Item | g.tec medical engineeringGmbHg.Estim FESThis Submission | Mettler Electronics Corp.SYS*STIM 208/208AK031017(secondary predicate) | Thought Technology LtdMyoTrac Infiniti K053266(reference) | Otto Bock HealthcareProduct GmbHSTIWELL med4 K080950(primary predicate) | Comments | |
| 3. | Power sources | USB and battery, 2 x 9 V | 110V AC, 60Hz +-10% | not publicly available | Battery Pack Li-ion 11,1 V | g.Estim FES is powered by acombination of batteries andUSB power. The applied part ispowered by conventionalbatteries and fulfills IEC 60601-1, therefore it is equivalent insafety and effectiveness. |
| 4. | Line currentisolation | The applied part is powered byconventional batteries. Theapplied part is isolated from therest of the circuit by 2 MOPaccording to IEC 60601-1. | AC power supply is convertedto DC power supply throughtransformer. Hence there is aninsulation of mains fromcircuitry. From circuitry tooutput again, there is insulationthrough the transformer, thereby double separation betweenmains and the human body. | not publicly available | Medical Class II PowerAdapter- Mascot (12,6 VDC-15,1W)) | State of the art isolation strategy- equivalent in safety andeffectiveness. |
| 5. | Patient leakagecurrent | Type BF according to IEC60601-1NC max: < 1 μA(IEC level NC <100 µA)SFC max: 2.6 µA(IEC level SFC <500 µA) | NC <100 µASFC < 300 µA | not publicly available | NC NA (Battery)SFC NA (Battery) | Below IEC standard thresholdsand therefore equivalent insafety and effectiveness. |
| 6. | Number ofoutput modes | 1 | 3:TetanizeSurgePulse | not publicly available | 1 | g.Estim FES allows a similarparameter range as MyoTracInfinity and STIWELL med 4and is equivalent in safety andeffectiveness. |
| 7. | Number ofoutput channels | 1 | 1 | not publicly available | 4 | g.Estim FES provides onechannel but is equivalent insafety and effectiveness. |
| 8. | Number ofEMG (input)Channels | NA | NA | not publicly available | 2 | g.Estim FES provides no EMGchannel and does not claimproduct category HCC, soequivalent in safety andeffectiveness for claimed |
| Item | g.tec medical engineeringGmbHg.Estim FESThis Submission | Mettler Electronics Corp.SYS*STIM 208/208AK031017 | Thought Technology LtdMyoTrac Infiniti K053266 | Otto Bock HealthcareProduct GmbHSTIWELL med4 K080950 | Comments | |
| 9. | EMG sensitivity | NA | NA | not publicly available | 1 μV | g.Estim FES provides no EMGchannel and does not claimproduct category HCC, soequivalent in safety andeffectiveness for claimedproduct codes. |
| 10. | EMG samplingRate | NA | NA | not publicly available | 3 kHz | g.Estim FES provides no EMGchannel and does not claimproduct category HCC, soequivalent in safety andeffectiveness for claimedproduct codes. |
| 11. | EMG detection(bipolar/monopolar) | NA | NA | Bipolar | Bipolar | g.Estim FES provides no EMGchannel and does not claimproduct category HCC, soequivalent in safety andeffectiveness for claimedproduct codes. |
| 12. | EMG range(μV) | NA | NA | 0-2000μV | 1-2000μV | g.Estim FES provides no EMGchannel and does not claimproduct category HCC, soequivalent in safety andeffectiveness for claimedproduct codes. |
| 13. | EMG bandwidth | NA | NA | 20-500Hz | 70-480Hz | g.Estim FES provides no EMGchannel and does not claimproduct category HCC, soequivalent in safety andeffectiveness for claimedproduct codes. |
| 14. | EMG signalprocessing (eg.RMS) | NA | NA | RMS (root mean square) | AVR (average reached value) | g.Estim FES provides no EMGchannel and does not claimproduct category HCC, soequivalent in safety andeffectiveness for claimedproduct codes. |
| 15. | Synchronous oralternatingchannels | NA | NA | not publicly available | Alternating | g.Estim FES provides onechannel but equivalent in safetyand effectiveness. |
| Item | g.tec medical engineeringGmbHg.Estim FESThis Submission | Mettler Electronics Corp.SYS*STIM 208/208AK031017 | Thought Technology LtdMyoTrac Infiniti K053266 | Otto Bock HealthcareProduct GmbHSTIWELL med4 K080950 | Comments | |
| 16. | Method ofchannelisolation | The applied part is isolatedfrom the rest of the circuit by 2MOP according to IEC 60601-1. | In this system, all the outputsare isolated from each other,they have their own amplifierswhich are independent fromneighboring channels oroutputs. The only commonthing between the outputs is themicroprocessor and the powersupply. | not publicly available | Transformer inductive couplers | State of the art isolation strategy- provides equivalent safety andeffectiveness. |
| 17. | Regulatedcurrent orregulatedvoltage | Regulated voltage, constantcurrent | Regulated current, constantvoltage | Regulated voltage, constantcurrent | Regulated Current | Constant current regulated butequivalent in safety andeffectiveness. |
| 18. | Software/Firmware/Microprocessor Control | • Microprocessor control• Firmware• Software | • Microprocessor control• Firmware | • Microprocessor control• Firmware | YES• Microprocessor control• Firmware• Software | g.Estim FES uses a software ona host computer for interfacingthe device via USB and stopsstimulation whencommunication loss is detected.Thus, equivalent in safety andeffectiveness is given |
| 19. | Automaticoverload trip | Yes | No | not publicly available | YES | g.Estim FES provides equalsafety and effectiveness as itstops when the required powercannot be delivered. |
| 20. | Automatic no-load trip | Yes | No | not publicly available | YES | g.Estim FES provides equalsafety and effectiveness as itstops when the required powercannot be delivered. |
| 21. | Automatic shutoff (timer range) | Yes | Yes | not publicly available | YES (10 min.) | Same as predicate |
| 22. | Patient overridecontrol | No | Yes, remote stop | not publicly available | YES (Stop Button) | g.Estim has no remote stop forpatient override control but isequivalent in safety andeffectiveness. |
| 23. | Indicatordisplay• On/off• Status• Low battery | YesYesYes | YesNAYes | not publicly available | YESYESYES | g.Estim FES displays therequired information so it isequivalent in safety andeffectiveness. |
| Item | g.tec medical engineeringGmbHg.Estim FESThis Submission | Mettler Electronics Corp.SYS*STIM 208/208AK031017 | Thought Technology LtdMyoTrac Infiniti K053266 | Otto Bock HealthcareProduct GmbHSTIWELL med4 K080950 | Comments | |
| · Voltage /Currentlevel | ||||||
| 24. | Timer range | 0-120 minutes | 0-60 minutes | 1-120 minutes | 2-120 min. | Higher range but equivalent insafety and effectiveness. |
| 25. | Standards | IEC60601-1IEC60601-1-2IEC60601-2-10ISO14971IEC62304IEC62366 | none | not publicly available | IEC60601-1IEC60601-1-2IEC60601-2-10 | More standardsapplied. |
| 26. | Compliancewith 21 CFR898 | Yes | Yes | not publicly available | YES | g.Estim FES is compliant to theCFR regulation and thereforeequivalent in safety andeffectiveness. |
| 27. | Weight | 0.85 kg | 2.25 lbs | not publicly available | 0,44 kg | Equivalent in safety andeffectiveness because weight iswithin the range of predicates. |
| 28. | Dimensions | 240 x 137 x 80 mm | 2.5 x 6 x 8 in | not publicly available | 175 x 95 x 30 mm | Biggest device but equivalent insafety and effectiveness |
| 29. | Housingmaterial andconstruction | ABS Plastic injection molded | ABS Plastic injection molded | not publicly available | Plastic | Same as predicate |
| 30. | Waveform | Symmetrical biphasic | Asymmetrical biphasic | Asymmetric biphasic | Symmetrical biphasic | Symmetrical biphasic,equivalent in safety andeffectiveness by providing azero-net charge. |
| 31. | Shape | rectangular | rectangular | not publicly available | rectangular | Same as predicate |
| 32. | Maximumoutput voltage | 30 V @ 500 Ω80 V @ 2 kΩ80 V @10 kΩ | 92 V @ 500 Ω144 V @ 2 kΩ166 V @10 kΩ | not publicly available | 50 V @ 500 Ω115 V @ 2 kΩNA @ 10 kΩ | Lower voltage but equivalent insafety and effectiveness. |
| 33. | Maximumoutput current | 0-60 mA @ 500 Ω0-40 mA @ 2 kΩ0-8 mA @10 kΩ | 184 mA @ 500 Ω72 mA @ 2 kΩ17mA @ 10 kΩ | 0-100mA @ 500 Ω | 100 mA @ 500 Ω58 mA @ 2 kΩNA @10 kΩ | Lower current but equivalent insafety and effectiveness. |
| 34. | Pulse width | 50-400 us | 182 us | 50-400 us | 50-400 us | Equivalent range and thereforeequivalent in safety andeffectiveness. |
| Item | g.tec medical engineeringGmbHg.Estim FESThis Submission | Mettler Electronics Corp.SYS*STIM 208/208AK031017 | Thought Technology LtdMyoTrac Infiniti K053266 | Otto Bock HealthcareProduct GmbHSTIWELL med4 K080950 | Comments | |
| 35. | Frequency | 1-100 Hz | Pulse: 1-80 HzTetanize: preset of 80 HzSurge: preset of 80 Hz | 2-100 Hz | 1-140 Hz | Equal range of frequency andtherefore equivalent in safetyand effectiveness. |
| 36. | Forinterferentialmodes onlyBeat frequency | NA | NA | not publicly available | NA | Same as predicates. |
| 37. | For multiphasicwaveforms onlysymmetricalphases | NA | NA | not publicly available | NA | Same as predicates. |
| 38. | For multiphasicwaveforms onlyphase duration(including units) | NA | NA | not publicly available | NA | Same as predicates. |
| 39. | Net charge @500 Ω , μC perpulse;Max. phasecharge 500 Ω | Zero, (achieved with biphasicpulse),max phase charge 24 µC | Zero, (achieved with biphasicpulse),max phase charge 56µC | max phase charge 60 µC | Zero, (achieved with biphasicpulse),max phase charge 40µC | Same zero net charge and lowermax. phase charge butequivalent in safety andeffectiveness. |
| 40. | Max. currentdensity | 3.056 mA/cm2 @ 500 Ω | 0.132 mA/cm2 @ 500 Ω | 0.24 mA/cm2 @ 500 Ω | 12.5 mA/cm2 @ 500 Ω | g.Estim FES provides anslightly reduced current densitybut is equivalent in safety andeffectiveness. |
| 41. | Max. powerdensity@ 500 Ωusing smallestelectrodeconductivesurface area | 7.33 mW/cm2 | 12 mW/cm2 | 16 mW/cm2 | 7.9 mW/cm2 | g.Estim FES has a reducedpower density but is equivalentin safety and effectiveness. |
| 42. | Burst ModePulses per burst | 2-2000 | not publicly available | not publicly available | –N/A | g.Estim FES has a reducedrange in pulses per burst but isequivalent in safety andeffectiveness. |
| 43. | Burst ModeBursts persecond | 1/70 - 1/4 | not publicly available | not publicly available | N/A | g.Estim FES has a comparablerange in burst per second but isequivalent in safety andeffectiveness. |
| Item | g.tec medical engineeringGmbHg.Estim FESThis Submission | Mettler Electronics Corp.SYS*STIM 208/208AK031017 | Thought Technology LtdMyoTrac Infiniti K053266 | Otto Bock HealthcareProduct GmbHSTIWELL med4 K080950 | Comments | |
| 44. | Burst ModeBurst duration(seconds)820.30C (H.36) | 2 sec. - 20 sec. | not publicly available | not publicly available | N/A | g.Estim FES has a comparablerange in burst duration, but isequivalent in safety andeffectiveness. |
| 45. | Bursts DutyCycle | 2/52 - 20/22 | not publicly available | not publicly available | N/A | g.Estim FES has a comparablerange in burst duty cycle, but isequivalent in safety andeffectiveness. |
| 46. | Duty cycle | On: 2-20 sec.Off: 2-50 sec. | Surge Mode: On 0,375-3,75sec.Off 0,375-3,75 sec. | On 2-20 sec.Off 2-50 sec. | On 1-20 sec.Off 1-50 sec. | g.Estim FES providesequivalent timer ranges -equivalent in safety andeffectiveness. |
| 47. | Additionalfeatures | NA | NA | NA | NA | Same as predicates. |
| 48. | Electrodes | Pepin K070807:WWS12o, WWS22 WWS2 | not publicly available | Axelgaard K874469A:# 895220; 895340 | not publicly available | g.Estim FES uses Pepinelectrodes but is equivalent insafety and effectiveness. |
| 49. | Electrodeconductivemedium | NA | not publicly available | not publicly available | not publicly available | Same as predicate |
| 50. | Electrode leadwires andpatient cables | Cable included, part number1163 | not publicly available | not publicly available | not publicly available | defined and equivalent in safetyand effectiveness |
| 51. | Batteries | Battery, 2 x 9 V | not publicly available | not publicly available | Battery Pack Li-ion 11,1 V | g.Estim FES uses two 9 Vbatteries but is equivalent insafety and effectiveness. |
| 52. | Battery charger | NA | not publicly available | not publicly available | Medical Class II PowerAdapter- | g.Estim does not use a poweradapter for charging but isequivalent in safety andeffectiveness. |
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Powered muscle stimulator comparison table
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| Item | g.tec medical engineeringGmbHg.Estim FESThis Submission | Additional predicate:Otto Bock HealthcareProduct GmbHSTIWELL med4 K080950 | Comments | |
|---|---|---|---|---|
| 53. | StimulatedMuscle | Wrist flexor/extensorFinger flexors/extensorsThumb flexor/extensor | Wrist extensorFinger flexorsThumb flexor | g.Estim FES is equivalent insafety and effectiveness. |
| 54. | Power sources | USB and battery, 2 x 9 V | Battery Pack Li-ion 11,1 V | g.Estim FES has an additionalUSB connection but isequivalent in safety andeffectiveness. |
| 55. | Line currentisolation | The applied part is powered byconventional batteries. Theapplied part is isolated from therest of the circuit by 2 MOPaccording to IEC 60601-1. | Medical Class II PowerAdapter | g.Estim FES line currentisolation is different but isequivalent in safety andeffectiveness. |
| 56. | Patient leakagecurrent | Type BF according to IEC60601-1NC max: < 1 μA(IEC level NC <100 μA)SFC max: 2.6 μA(IEC level SFC <500 μA) | NC NA (Battery)SFC NA (Battery) | NC and SFC are considerdbecause of different powersources but are equivalent insafety and effectiveness. |
| 57. | Number ofoutput modes | 1 | 1 | Same as predicate |
| 58. | Number ofoutput channels | 1 | 3 | g.Estim FES provides onechannel but is equivalent insafety and effectiveness. |
| 59. | Number ofEMG (input )Channels | NA | 0 | Same as predicate |
| 60. | EMGsensitivity | NA | NA | Same as predicate |
| 61. | EMG samplingRate | NA | NA | Same as predicate |
| 62. | EMG detection(bipolar/monopolar) | NA | NA | Same as predicate |
| 63. | EMG range(µV) | NA | NA | Same as predicate |
| 64. | EMG bandwidth | NA | NA | Same as predicate |
| 65. | EMG signalprocessing (eg.RMS) | NA | NA | Same as predicate |
| 66. | Synchronous oralternatingchannels | NA | Alternating | g.Estim FES provides onechannel but is equivalent insafety and effectiveness. |
| 67. | Method ofchannelisolation | The applied part is isolatedfrom the rest of the circuit by 2MOP according to IEC 60601-1. | Transformer inductive couplers | State of the art isolation strategy- equivalent in safety andeffectiveness. |
| 68. | Regulatedcurrent orregulatedvoltage | Regulated voltage, constantcurrent | Regulated current | Constant current regulated butequivalent in safety andeffectiveness. |
| 69. | Software/Firmware/Microprocessor Control | • Microprocessor control• Firmware• Software | • Firmware | g.Estim FES uses a software ona host computer for interfacingthe device via USB and stopsstimulation whencommunication loss is detected.Thus, equivalent in safety and |
| Item | g.tec medical engineeringGmbHg.Estim FESThis Submission | Additional predicate:Otto Bock HealthcareProduct GmbHSTIWELL med4 K080950 | Comments | |
| 70. | Automaticoverload trip | Yes | YES | g.Estim FES provides equalsafety and effectiveness as itstops when the required powercannot be delivered. |
| 71. | Automatic no-load trip | Yes | YES | g.Estim FES provides equalsafety and effectiveness as itstops when the required powercannot be delivered. |
| 72. | Automatic shutoff (timer range) | Yes | YES (10 min.) | Same as predicate |
| 73. | Patient overridecontrol | No | YES (Stop Button) | g.Estim has no remote stop forpatient override control but isequivalent in safety andeffectiveness. |
| 74. | Indicatordisplay• On/off• Status• Low battery• Voltage / Currentlevel | YesYesYes | YESYESYES | Same as predicate. |
| 75. | Timer range | 0-120min. | 15-60 min. | Higher timer range of g.EstimFES but equivalent in safetyand effectiveness. |
| 76. | Standards | IEC60601-1IEC60601-1-2IEC60601-2-10ISO14971IEC62304IEC62366 | IEC60601-1IEC60601-1-2IEC60601-2-10 | More standardsapplied. |
| 77. | Compliancewith 21 CFR898 | Yes | YES | g.Estim FES is compliant to theCFR regulation and thereforeequivalent in safety andeffectiveness. |
| 78. | Weight | 0.85 kg | 0,44 kg | Heavier but equivalent insafety and effectiveness. |
| 79. | Dimensions | 240 x 137 x 80 mm | 175 x 95 x 30 mm | Bigger dimensions butequivalent in safety andeffectiveness. |
| 80. | Housingmaterial andconstruction | ABS Plastic injection molded | Plastic | Injection molded ABS is usedbut is equivalent in safety andeffectiveness. |
| 81. | Waveform | Symmetrical biphasic | Symmetrical biphasic | Same as predicate. |
| 82. | Shape | rectangular | rectangular | Same as predicate |
| 83. | Maximumoutput voltage | $30 V @ 500 \Omega$$80 V @ 2 k\Omega$$80 V @10 k\Omega$ | $50 V @ 500 \Omega$$115 V @ 2 k\Omega$NA @ 10 kΩ | Lower voltage and phase chargebut equivalent in safety andeffectiveness. |
| 84. | Maximumoutput current | $0-60 mA @ 500 \Omega$$0-40 mA @ 2 k\Omega$$0-8 mA @ 10 k\Omega$ | $100 mA @ 500 \Omega$$58 mA @ 2 k\Omega$NA @10 kΩ | Lower current and phase chargebut equivalent in safety andeffectiveness. |
| 85. | Pulse width | 50-400 μs | 50-400 μs | Same as predicate. |
| 86. | Frequency | 1-100 Hz | 1-140 HzDefault 35Hz | Lower frequency and power butequivalent in safety andeffectiveness. |
| 87. | Forinterferentialmodes onlyBeat frequency | NA | NA | Same as predicates. |
| 88. | For multiphasic | NA | NA | Same as predicates. |
| Item | g.tec medical engineeringGmbHg.Estim FESThis Submission | Additional predicate:Otto Bock HealthcareProduct GmbHSTIWELL med4 K080950 | Comments | |
| symmectricalphases | ||||
| 89. | For multiphasicwasveformsonly phaseduration(including units) | NA | NA | Same as predicates. |
| 90. | Net charge (µCper pulse) | Zero, max phase charge 24 µC | Zero, same positive andnegative impulse, max phasecharge 40µC | Lower phase charge butequivalent in safety andeffectiveness. |
| 91. | Max. currentdensity | 3.056 mA/cm² @ 500 Ω | 12.5 mA/cm² @ 500 Ω | g.Estim FES has a reducedcurrent density but is equivalentin safety and effectiveness. |
| 92. | Max. powerdensity | 7.33 mW/cm² | 7.9 mW/cm² | g.Estim FES has a reducedpower density but is equivalentin safety and effectiveness. |
| 93. | Burst ModePulses per burst | 2-2000 | N/A | g.Estim FES has a reducedrange in pulses per burst but isequivalent in safety andeffectiveness. |
| 94. | Burst ModeBursts persecond | 1/70 - 1/4 | N/A | g.Estim FES has a similar rangein burst per second but isequivalent in safety andeffectiveness. |
| 95. | Burst ModeBurst duration(seconds) | 2 sec. - 20 sec. | N/A | g.Estim FES has a comparablerange in burst duration, but isequivalent in safety andeffectiveness. |
| 96. | Bursts DutyCycle | 2/52 - 20/22 | N/A | g.Estim FES has a comparablerange in burst duty cycle -equivalent in safety andeffectiveness. |
| 97. | Duty cycle | On: 2-20 sec.Off: 2-50 sec. | On 1-20 sec.Off 1-30 sec. | g.Estim FES providesequivalent timer ranges -equivalent in safety andeffectiveness. |
Functional Electrical Stimulation comparison Table
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g.tec medical engineering GmbH, Sierningstrasse 14, 4521 Schiediberg, Austria, Europe,
Tel.: +43 7251 22240, Fax: +43 7251 22240-39, office@gtec.at, www.gtec.at
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| RecognictionNumber | Standard / Description |
|---|---|
| 19-4 | AAMI ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 andA2:2010/(R)2012Medical Electrical Equipment - Part 1: General requirements for basic safetyand essential performance |
| 19-8 | IEC 60601-1-2 Edition 4.0 2014-02:Medical electrical equipment - Part 1-2: General requirements for basic safetyand essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests |
| 13-79 | IEC 62304 Edition 1.1 2015-06Medical device software - Software life cycle processes |
| 5-40 | ISO 14971 Second edition 2007-03-01Medical devices - Application of risk management to medical devices |
| 5-114 | IEC 62366-1 Edition 1.0 2015-02Medical devices - Part 1: Application of usability engineering to medicaldevices [Including CORRIGENDUM 1 (2016)] |
| 17-16 | IEC 60601-2-10 Edition 2.1 2016-04Medical electrical equipment - Part 2-10: Particular requirements for the basicsafety and essential performance of nerve and muscle stimulators |
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807.92(b)(1)
The stimulator was tested with a data acquisition device and provides rectangular stimulation pulses with the necessary frequency and amplitude range. Furthermore digital outputs were tested to provide trigger signals and digital inputs were tested to trigger the stimulation. The impedance measurement was tested with test impedances. The tests show that the stimulator works like the predicate device.
In g.Estim FES medical safety is realized by isolating the applied part optically from the data transmission via USB and by battery supply. The current for the impedance measurement is limited with resistors.
807.92(b)(2) Not applicable
807.92(b)(3)
The conclusion is that g.Estim FES and the predicate device provide electrical stimuli with varying pulse width, frequency and amplitude in the same way and that the g.Estim FES is substantially equivalent to the predicate device.
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).